"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(micafungin sodium) for Intravenous Infusion
Mycamine is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1, 3-beta-D-glucan, an integral component of the fungal cell wall.
Each single-use vial contains 50 mg or 100 mg micafungin sodium, 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Mycamine must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see DOSAGE AND ADMINISTRATION]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5-7.
Micafungin sodium is chemically designated as:
Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy)phenyl]-3isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-Lthreonine]-, monosodium salt.
The chemical structure of micafungin sodium is:
The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26.
Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.
What are the possible side effects of micafungin (Mycamine)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- pale skin, dark colored urine, confusion or weakness;
- upper stomach pain, itching, clay-colored stools, jaundice (yellowing of the skin or eyes);
- fever, chills, body aches, flu symptoms;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under...
What are the precautions when taking micafungin sodium (Mycamine)?
Before using micafungin, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, blood disorders (e.g., anemia, decreased bone marrow function).
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 8/26/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Mycamine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.